Evaluation of Abdominal Tissue Oxygenation in Premature Infants Using Near Infrared Spectroscopy

August 23, 2015 updated by: Ricardo Castillo-Galvan, MD, Brigham and Women's Hospital

There is an increasing incidence of Necrotizing Enterocolitis (NEC) affecting the premature infant population, principally those with associated risk like extreme prematurity, extreme low birth weight, associated co-morbidities (Congenital heart disease, perinatal asphyxia) and those born in hospitals with limited resources for optimal neonatal care.

Near Infrared Spectroscopy (NIRS), has been used in premature infants to evaluate changes in cerebral perfusion and oxygenation. (1) It provides real time insight into the oxygen delivery.(3) In the premature patient population, many neurologic injuries occur as a result of prenatal (pre-existing) and/or postnatal disturbance on oxygen delivery. NIRS has been focused in cerebral monitoring. Light easily penetrates through neonatal bone and skin tissue, and allows to monitor the subjacent oxygen content. Early studies were performed to validate NIRS measurements and have established normative data.(4-6) The non-invasive method of monitoring cerebral hemodynamics and oxygenation has revolutionized the intensive care units in patients at risk for neurological injuries. This method has been successfully validated to monitor neonatal cerebral oxygenation in different clinical settings and study protocols. (7) NIRS provides non-invasive, continuous information on tissue perfusion and oxygen dynamics.

One of the biggest challenges of NEC spectrum diseases is in the making of early diagnosis. It is important to monitor not just cerebral perfusion but also the intestinal oxygenation.(8,9) Previous studies with NIRS have demonstrated that premature infants change their cerebral - splanchnic oxygenation ratios during feedings.(10) Guy et al. performed NIRS in premature piglets to demonstrate association of perfusion change with NEC spectrum(11,12); these studies suggest evidence that NIRS could be a useful diagnostic tool in the premature infant population trough abdominal NIRS (a-NIRS) measurement capable of detecting alterations in intestinal oxygenation and perfusion.

In summary, a-NIRS could be use in the premature infant population to define reference values, especially in patients at risk, which would then facilitate the early diagnosis of NEC spectrum diseases.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

We will include, 10 premature infants from 32 to 36 weeks of post menstrual age, within the first week of life, that are clinically stable without diagnosis of Congenital Heart Disease, Necrotizing Enterocolitis, Sepsis or having been transfused less than three days before the evaluation. Infants with abdominal injuries, omphalocele, gastroschisis and abdominal skin irritation that does not permit the application of the probes will also be excluded.

10 premature infants from 32 to 36 weeks of post menstrual age will be included, after their first week of life, clinically stable status, and without diagnosis of Congenital Heart Disease, Necrotizing Enterocolitis, Sepsis or blood transfused less than three days before the moment of the evaluation. Infants with abdominal injuries, Omphalocele, Gastroschisis, skin irritation also will be excluded. NIRS device will record and monitor the Regional Oxygen Saturation (rSO2) in the infant during one week.

The evaluation will take place ar the Neonatal Intensive Care Unit (NICU), 6th floor at the Mary Horrigan Connors Center for Women's Health, Brigham and Women's Hospital. (http://www.brighamandwomens.org/newbornmedicine)

We will use a Near infrared spectroscopy (NIRS) device the INVOS 5100c (Covidien), catalogued under de Investigational Device Exemption (IDE) as 'non-significant risk device' (21 CFR 812.2) in order to perform monitoring as well as record-keeping with non-risk for the subject. No need Food and Drug Administration (FDA) clearance.

The application of the INVOS 5100c (Covidien) sensor optodes will be positioned in four locations (four channels), these will be in the lower abdomen, taking place bellow the umbilicus, with care, flush against the skin; in the submandibular region; upper left abdomen as well as in the thigh either left or right.

If the clinical status change during the monitoring, this could be discontinued under the criteria of the attending neonatologist in charge.

Once included, the sensors will be placed in the described areas and the team will reassure the quality of the lecture obtained. The rSO2 recordings will be continuously monitored for seven days, after this period of time, prospective observational following of patient data and outcomes will be implemented.

Clinical outcome data will be correlated with tissue oxygen saturation, other outcome variables will include length of NICU stay, morbidity, mortality, laboratory studies, oxygen saturation by standard pulse oximetry and continuous outcome variables will be analyzed using the Analysis of Variance (ANOVA) formula; mortality will be analyzed using Student's t-test. For the remaining variables (vital signs, lab values, oxygen saturation, morbidity, mortality), data will be extracted from clinical records and entered it into the electronic database.

The study staff, principal investigator, and co-investigators will identify potential subjects meeting the inclusion/exclusion criteria. Potential subjects will be identified by talking to the attending in charge at the NICU. Cases will be identified by communicating with the NIRS/NICU research team at Brigham and Women's Hospital.

Informed consent will be obtained from the parent(s) or guardian(s) under the Research involving no greater than minimal risk condition (46.404) where at least one of the parents must provide the permission.

In all cases we will approach the attending physician of prospective subjects to describe the study and obtain verbal consent to approach patients for recruitment; the attending physician or medical staff caring for the patient will be the first to make contact with the patients parents or guardian to describe the study briefly and ask permission for us to explain the study in more detail.

A review of the data will be conducted by a physician and a clinical review team. The principal investigator and study staff will be constantly monitoring and reviewing the rights, safety and welfare of all subjects in this trial through out the study.

In addition, the principal investigator will review any adverse events and report in accordance with the Partners Human Research Committees (PHRC) regulations.

Study Type

Observational

Enrollment (Anticipated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Brigham and Women's Hospital Newborn Medicine Department
        • Contact:
        • Sub-Investigator:
          • Steven A Ringer, MD, PhD
        • Principal Investigator:
          • Ricardo Castillo-Galvan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 weeks (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Preterm infants (Premature Infants) from 32 to 36 weeks of post menstrual age hospitalized in the Neonatal Intensive Care Unit (NICU) at Brigham and Women's Hospital.

Description

Inclusion Criteria:

  • Preterm infant (32 to 36 weeks of postmenstrual age)
  • Neonatal intensive care unit (NICU) patient
  • Stable clinical condition (i.e. Vital signs, Hemodynamics)
  • Age less than 6 weeks of life

Exclusion Criteria:

  • Congenital Heart Disease
  • Necrotizing enterocolitis prior to inclusion
  • Non stable clinical condition
  • Blood transfused less than three days prior to inclusion
  • Abdominal injuries (i.e. Omphalocele, Gastroschisis, Skin irritation) that impedes placement of the optodes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Preterm infants
Preterm infants (32 to 36 weeks of postmenstrual age) will be evaluated with a Near infrared Spectroscopy monitor device.
Device: Near Infrared Spectroscopy
NIRS Monitoring with four channels regional areas of the preterm infant, such as: Submandibular, Periumbilical, Abdominal (Spleen region) and infant thigh.
Other Names:
  • Near Infrared Spectroscopy (NIRS)
  • NIRS Device
  • NIRS Monitor
  • INVOS 5100c
  • OxyAlert

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abdominal Tissue Oxygenation in Preterm Infant
Time Frame: 5 days
Abdominal Tissue Oxygenation will be assessed with the Near Infrared Spectroscopy (NIRS) device, the INVOS 5100c with a time frame of one week in each of the participants, this device will monitor the oxygen tissue status in percentage unit. This outcome measure will be compare during this time frame and the underlying clinical status of the neonate. We then will look for an association between low percentages in the outcome measure and clinical evidences of Necrotizing Enterocolitis.
5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Submandibular Tissue Oxygenation in Preterm Infant
Time Frame: 5 days

Submandibular Tissue Oxygenation will be assessed with the INVOS 5100c NIRS device in real time along with the abdominal oxygenation (Primary outcome) and we will follow it principally during feedings.

It is also expressed in percentage.
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Investigators

  • Principal Investigator: Ricardo Castillo-Galvan, MD, Brigham and Women's Hospital
  • Study Chair: Maxwell Weinmann, MD, Brigham and Women's Hospital
  • Study Director: Steven A Ringer, MD, PhD, Brigham and Women's Hospital
  • Study Chair: Edward Kelly, MD, Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (ANTICIPATED)

June 1, 2016

Study Completion (ANTICIPATED)

July 1, 2016

Study Registration Dates

First Submitted

May 14, 2013

First Submitted That Met QC Criteria

May 14, 2013

First Posted (ESTIMATE)

May 16, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

August 25, 2015

Last Update Submitted That Met QC Criteria

August 23, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BWH-NICU/NIRS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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